Advanced Therapies

Swissmedic issues guideline on gene therapy risks

The Swiss regulator, Swissmedic, has issued a new guideline on assessing the risk to humans and the environment in relation to clinical trials for somatic gene therapy¹.

The guideline is intended to allow for the rapid and efficient evaluation of applications for these types of clinical trials by providing the details of the environmental data (ie risk assessment) that must be submitted to Swissmedic with an application. The guideline also applies to clinical trials for medicines containing genetically modified micro-organisms.

It takes into account the fact that the investigational products in question are usually viral vectors, plasmids or bacteria, and therefore focuses on the risks of the investigational product being excreted by the trial subject, who could in turn release it into the environment. To that end, Swissmedic stresses that the investigational product's replication capacity or reversion to replication capacity should be taken into account in the risk assessment.

The objective of a risk assessment is to determine and assess all possible direct, indirect, immediate or long-term harmful effects on humans and the environment if the investigational product is released. At a minimum, the guideline says that an assessment must include details of the possible harmful effects of the product (damage potential) as well as the extent of such damage. In addition, it should provide information on the likelihood of damage and possible exposure of humans or the environment to the product and the associated risks. Finally, all risk assessments must provide details of the required safety measures to minimise the determined risk and explain the risk that remains when those safety measures are met.

The guideline sets out the required documentation to be submitted in three scenarios:

• Case A, which is based on the assumption that the investigational product will not be excreted by trial subjects;

· Case B1, which is based on the assumption that the product will be excreted by trial subjects, but not released into the environment; and

· Case B2, which is based on the assumption that the product will be released into the environment.

The document was jointly developed by Swissmedic (based on the Ordinance on Clinical Trials with Therapeutic Products), the Federal Office of Public Health (FOPH), the Federal Office for the Environment (FOEN) and the Swiss Expert Committee for Bioasafety (SECB).

ALAN CHALMERS

References

1. Swissmedic, Gene Therapy/GMO Environmental Data Guideline, 6 July 2007, www.swissmedic.ch/files/pdf/B3.1.153-e.pdf#xml=http://www.swissmedic.ch/texis/texis.exe/webinator/swissmedic_en/xml.txt?query=gene+therapy&pr=swissmedic_en&order=r&cq=4&id=46db44ce3